News Scan for Oct 02, 2019

MERS in Saudi Arabia
FDA review of kids' C diff treatment
Local dengue in Spain, France
Cholera vaccine campaign

Saudi Arabia records new MERS case in southwest

Saudi Arabia's Ministry of Health (MOH) today reported another MERS-CoV case, the first in October. The case-patient is from Abha, a city in the southwestern region of the country.

The new MERS-CoV (Middle East respiratory syndrome coronavirus) case involves a 34-year-old man with unknown camel exposure. His illness is listed as "primary," meaning it's unlikely he contracted the virus from another person.

As of Sep 19, the WHO's Eastern Mediterranean regional office said that, since 2012 there have been 2,468 MERS cases, at least 850 of them fatal. The vast majority of infections have been in Saudi Arabia, which reported four MERS cases in September.
Oct 1 MOH


FDA grants priority review for fidaxomicin for C diff in kids

Merck announced today that the US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and a supplemental NDA for use of different fidaxomicin (Dificid) formulations in treating Clostridioides difficile infections in children ages 6 months and older.

In a news release, Merck, of Kenilworth, New Jersey, said the NDA is for the oral suspension of the drug and the supplemental NDA is a new indication for use of tablets and oral suspension. The FDA has granted priority review for both applications, and the Prescription Drug User Fee Act (PDUFA) date for both applications is Jan 24, 2020. The FDA granted Orphan Drug Designation for the investigational pediatric indication in 2010.

Nicholas Kartsonis, MD, Merck's senior vice president for clinical research, infectious diseases, and vaccines, said in the release that evidence suggests the incidence of C difficile diarrhea in hospitalized children is increasing. "The filings for the pediatric indication for the new investigational oral suspension formulation of DIFICID, as well as for DIFICID tablets, underscore Merck's focus and dedication to developing infectious disease treatments for those with unmet needs," he said.

The company said the supplemental NDA is based mainly on findings of a phase 3 study that was presented at IDWeek 2018 in San Francisco.

Fidaxomicin is a macrolide antibacterial medication currently indicated for adults for treating C diff diarrhea. In 2018 the Infectious Diseases Society of America recommended fidaxomicin as a first-line therapy for treating C diff infections, the first time those recommendations addressed pediatric treatment of the disease.
Oct 2 Merck press release


ECDC: Local dengue cases in Spain, France pose low risk

Following reports of three locally acquired dengue detections—one in Spain and two in France—the European Centre for Disease Prevention and Control (ECDC) today said the risk of sustained transmission is low.

Spain's case involves a patient from Catalonia whose symptoms began on Sep 6 and had not traveled outside the country.

One French patient is from Alpes Maritimes department and became ill on Aug 30 and reported no travel outside of mainland France. Door-to-door surveillance around the person's house identified four additional cases that were likely not locally acquired. The country's other illness is classified as probable and involves an individual from a suburb of Lyon in Rhone department whose symptoms began on Jul 14. Lab confirmation is still under way.

The ECDC said there are no epidemiologic connections between the three events, so they are considered to be independent. It added that sporadic locally acquired cases and clusters are expected in Europe's Mediterranean region and southern parts of European nations in the summer and fall because of established Aedes albopictus populations and the large volume of travelers returning from countries where vector-borne diseases such as dengue and chikungunya are endemic.

The probability of sustained transmission is very low in both countries, because environmental conditions over the fall will become less suitable for mosquito populations.
Oct 1 ECDC rapid risk assessment


WHO, UNICEF aim to vaccinate 1.6 million against cholera in Sudan

The World Health Organization (WHO) and the United Nations Children Fund (UNICEF) have partnered, with the aim of vaccinating 1.6 million Sudanese against cholera, according to a UN statement yesterday.

Since Sep 8, Sudan has confirmed 215 cases of cholera, including 8 deaths, as part of an outbreak in Blue Nile state. The oral cholera vaccination campaign will launch in mid-October, and target those in the Blue Nile as well as Sinnar states.

"Sudan has bad health infrastructure and a dilapidated safe water and sewage system," said WHO spokesperson Tarik Jasarevic yesterday in Geneva. "Re-occurring floods have further led to polluting water sources. All of these factors heighten the risk of cholera and other diarrheal diseases and threaten to cause a wide spread if no immediate response interventions are not [sic] adopted."

Cholera is caused by ingesting food or water contaminated with a bacterium called Vibrio cholorae. Patients who develop cholera experience watery diarrhea, which can lead to severe dehydration and death.

Sudan last saw a major cholera outbreak from 2016 to 2018, when 37,000 cases were recorded, including 823 deaths.
Oct 1 UN

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